Acorda just entered a world of hurt.
With its patent protection crumbling around its mainstay drug, the FDA has refused to file its application for CVT-301, the rescue program that was designated to take the lead drug’s place. The RTF creates an embarrassing and perhaps crippling problem for the biotech, which is fighting a last-ditch battle to maintain patent protection on its one big drug, Ampyra.
According to Acorda, the FDA says the company’s marketing application, rushed to regulators as the company restructured and downsized, is incomplete. Regulators said they were unable to do a proper review as they don’t know what date Acorda’s manufacturing center will be ready for inspection and have a “question regarding the submission of the drug master production record.”
Acorda reported that the FDA also requested additional information at resubmission, which was not part of the basis for the RTF.
Its shares quickly plunged 26% on the news.
Normally, a delay like this would be seen as a sticky problem, but one that could potentially be resolved without huge delays. The problem for Acorda, though, is that the company has virtually no leeway for a snafu like this. Not only does it leave Acorda’s executive team with a black eye on execution, it creates serious doubts about its ability to quickly and efficiently line up a replacement drug for its sales team by next summer, as the litigation over its patents for Ampyra comes to a head.
Leerink’s Paul Matteis found the whole thing puzzling and disconcerting, considering the likelihood of a looming approval. And he still has questions about what is going on at Acorda.
It seems like the best case scenario would be a re-submission around the end of this year, and its encouraging that FDA did not make any requests regarding the efficacy or safety data. Nonetheless, even after speaking with the company, the RTF is mysterious to us, and we expect the stock to be under pressure until opacity is lifted.
As I reported in June, while reviewing the late-stage data submitted to the FDA on the inhaled levodopa, any setback on CVT-301 would be a catastrophe for Acorda.
Acorda shifted to survival mode in early April after a US district court tossed four key patents on its flagship drug Ampyra, leaving it with one to stand on into next year. The company chopped 20% of its staff as it scrambles to restructure while gambling that it can field new drugs in short order.
Now Acorda is left to desperately seek a quick meeting with regulators to clear up any of these questions. But the FDA is not known for scrambling a response in any of these situations, leaving Acorda’s timeline in the air just when it most needs certainty. Just weeks ago one of its biggest investors pushed CEO Ron Cohen to auction the company off rather than risk the consequences of failing at its high wire act. The company pushed back, but a sale may come back on the table now whether or not it likes the idea.
“We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” said Cohen in a statement. “We remain confident in INBRIJA’s data package and its promise as an important new therapy for people with Parkinson’s disease. We see tremendous long-term value in its solid clinical profile, significant commercial opportunity and strong IP, and we remain focused on working to bring patients this important new therapy.”
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